Recent BioBlast® Updates

JAMP Loses Canadian ‘Abuse of Dominance’ Application Against Janssen Regarding Stelara® (Ustekinumab)

Nov 20, 2024

We reported on 26 August 2024 that JAMP had filed an application in the Canadian Competition Tribunal seeking leave to bring an action under the Competition Act regarding Stelara®

Approval Alert: FDA Approves Jazz Pharmaceutical’s Ziihera® (Zanidatamab-hrii) for Biliary Tract Cancer

Nov 20, 2024

On 20 November 2024, Jazz Pharmaceuticals announced that the US FDA has granted accelerated approval of Ziihera® (zanidatamab-hrii) for the treatment of adults with previously treated, unresectable or metastatic HER2-positive (IHC 3+) biliary tract cancer, as detected...

Approval Alert: Pfizer’s Hympavzi™ (Marstacimab) Receives EU Approval

Nov 20, 2024

On 20 November 2024, Pfizer announced that the European Commission (EC) has approved its Hympavzi™ (marstacimab) for the routine prophylaxis of bleeding episodes in patients 12 years of age and older weighing at least 35 kg with severe haemophilia A without FVIII...

New Indication Alert: FDA Approves UCB’s Bimzelx® (Bimekizumab-bkzx) as First IL-17A/IL-17F Inhibitor for Hidradenitis Suppurativa

Nov 20, 2024

On 20 November 2024, UCB announced that Bimzelx® (bimekizumab-bkzx) was approved by the FDA as the first IL-17A and IL-17F inhibitor for adults with moderate to severe hidradenitis suppurativa. This follows the recommendation of the EMA’s Committee for Medicinal...

Novo Nordisk Launches Wegovy® in China

Nov 19, 2024

On 19 November 2024, Reuters reported that Novo Nordisk has launched Wegovy® (semaglutide) in China. The report states that sales will initially be made without insurance subsidy, although Novo Nordisk is investigating mechanisms to reduce costs for Chinese...

Supreme Court of India Directs Delhi HC to Reconsider Injunction Against Zydus’ Pertuzumab Biosimilar

Nov 19, 2024

On 19 November 2024, the Economic Times reported that the Supreme Court of India has directed the Delhi High Court to move quickly on reconsidering an injunction, which was reinstated in October 2024, preventing Zydus from manufacturing, selling and marketing...

MSD’s Positive Phase 3 Results for Subcutaneous Pembrolizumab

Nov 19, 2024

On 19 November 2024, MSD (Merck in the US and Canada) announced positive topline results from its Phase 3 trial evaluating subcutaneous (SC) administration of pembrolizumab, together with Alteogen’s berahyaluronidase alfa, administered with chemotherapy. The SC...

Xbrane and Intas to Jointly Develop Nivolumab Biosimilar

Nov 19, 2024

On 19 November 2024, Xbrane and Intas announced they have entered an exclusive, global licensing and co-development agreement in relation to Xbrane´s nivolumab biosimilar candidate (referencing BMS’ Opdivo®). The biosimilar will be commercialised through Intas’...

Canada’s Drug Agency Recommends Against Reimbursement of Ebglyss™ (Lebrikizumab)

Nov 19, 2024

On 15 November 2024, Canada's Drug Agency (CDA-AMC) published its final recommendation for Eli Lilly’s Ebglyss™ (lebrikizumab), recommending against reimbursement of Ebglyss™ by public drug plans, excluding Quebec, for the treatment of moderate-to-severe atopic...

Regeneron Sues Sanofi For Breach of Dupixent® Collaboration Agreement

Nov 18, 2024

Regeneron has sued Sanofi, its partner in the commercialisation of the blockbuster eczema drug Dupixent® (dupilumab), in the US District Court for the Southern District of New York alleging that Sanofi is in breach of its commercialisation agreement. The issues...

Approval Alert: AbbVie’s Elahere® (Mirvetuximab Soravtansine) EU-Approved for Platinum-Resistant Ovarian Cancer

Nov 18, 2024

On 18 November 2024, AbbVie announced that European Commission (EC) has approved Elahere® (mirvetuximab soravtansine) for the treatment of adult patients with folate receptor-alpha (FRα) positive, platinum-resistant high-grade serous epithelial ovarian, fallopian tube...

Celltrion Publishes Additional Phase 3 Study Results Supporting Denosumab and Tocilizumab Biosimilars

Nov 18, 2024

In April 2024, we reported that Celltrion presented the 78-week results of its Phase 3 study of CT-P41, biosimilar to Amgen’s Prolia® (denosumab), and published those results in late July. On 18 November 2024, Celltrion presented additional data from that trial. ...

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Recent BioBlast® Updates

JAMP Loses Canadian ‘Abuse of Dominance’ Application Against Janssen Regarding Stelara® (Ustekinumab)

Approval Alert: FDA Approves Jazz Pharmaceutical’s Ziihera® (Zanidatamab-hrii) for Biliary Tract Cancer

Approval Alert: Pfizer’s Hympavzi™ (Marstacimab) Receives EU Approval

New Indication Alert: FDA Approves UCB’s Bimzelx® (Bimekizumab-bkzx) as First IL-17A/IL-17F Inhibitor for Hidradenitis Suppurativa

Novo Nordisk Launches Wegovy® in China

Supreme Court of India Directs Delhi HC to Reconsider Injunction Against Zydus’ Pertuzumab Biosimilar

MSD’s Positive Phase 3 Results for Subcutaneous Pembrolizumab

Xbrane and Intas to Jointly Develop Nivolumab Biosimilar

Canada’s Drug Agency Recommends Against Reimbursement of Ebglyss™ (Lebrikizumab)

Regeneron Sues Sanofi For Breach of Dupixent® Collaboration Agreement

Approval Alert: AbbVie’s Elahere® (Mirvetuximab Soravtansine) EU-Approved for Platinum-Resistant Ovarian Cancer

Celltrion Publishes Additional Phase 3 Study Results Supporting Denosumab and Tocilizumab Biosimilars

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